HACCP inspections—what to expect from FDA

Wondering how HACCP inspections will work after December 1997? You're not alone.
Rick Licari, enforcement officer with the Food and Drug Administration (FDA)
Boston District, delivered the following (summarized) remarks at a meeting of
the New England Fisheries Development Association (NEFDA).

Licari had been asked to describe how FDA planned to implement the mandatory
HACCP-based seafood safety program which took effect December 1997.

The following is a summary of Licari's remarks as published in the NEFDA newsletter
and reprinted in Fisheries Product News, vol. 12 no. 4, 1997. It is
reprinted here by permission.

When your seafood handling facility is visited by an FDA inspector, you may
expect the following:

(1) The FDA inspector will continue to look for violations of other regulations
and statutes such as those relating to economic fraud, filth, decomposition,
sanitation and GMP while conducting a HACCP inspection.

(2) The HACCP inspection will consist of:

(a) initial interview

(b) inspector will conduct own hazard analysis

(c) and review processor's hazard analysis

(d) evaluate processor's HACCP plan

(e) determine whether it is being followed

(f) review records

(g) document objectionable conditions.

(3) In the initial interview typical questions will be:

"What seafood products do you process?"

"What are you processing today?"

"Do you have a HACCP plan for these products?"

"Do you have sanitation standard operating procedures?"

The investigator will probably select for inspection the product which has
the greatest potential for a safety hazard.

(4) During the "walk through" phase the investigator will be developing his/her
hazard analysis, including process flow and the firm's preventive measures
by observation and interview.

(5) If the firm allows it, the inspector will compare his/her hazard analysis
with the firm's. If the firm does not allow the investigator to review its
hazard analysis, the investigator will then determine what hazards the firm
considered critical from the firm's HACCP plan and will question how the firm
determined its critical hazards. Inspectors are encouraged to discuss differences
between their judgments of hazards and the firm's.

(6) The HACCP plan evaluation includes evaluation of the written plan, training
of the individual who developed the plan, the signature of the company official
who accepted the plan and judgments about technical aspects of the plan, including
appropriateness of critical limits, monitoring procedures, calibration of monitoring
instruments, identity of proper records and appropriateness of verification
procedures.

(7) Next, the investigator will evaluate the firm's implementation of the
HACCP plan, ideally by observing what actually happens on the production floor.

(8) An evaluation of the firm's HACCP records will show whether the HACCP
plan is properly and consistently implemented, including monitoring records,
corrective action records and verification records. Verification records could
include calibration of instruments and any end-product or in-process testing
specified in the HACCP plan. The investigator will be looking for the identity
and address of the firm, the identity of the product being processed, recording
of the actual values observed, date and time of monitoring activities, initials
of operator and signature of reviewer and date of review.

(9) The HACCP regulations include new sanitation requirements and require
processors to monitor their operation to ensure compliance with certain parts
of the Part 110 GMPs, and results of this monitoring and any corrections must
be documented in records. The inspection will include these requirements.

(10) Inspectors will document any violations of the seafood HACCP regulations
encountered in their inspection and will review objectionable conditions with
management before leaving.

(11) From December 18, 1997, to September 18, 1998, FDA expects to inspect
over 1,000 of the 1,200 domestic substantial risk firms in the FDA database.
(A substantial risk firm is one that processes a product which has a strong
likelihood to potentially cause health consequences.)

Imported seafood

(12) Until an MOU (Memorandum of Understanding) has been established between
FDA and exporting country, importers must have a product specification for
each seafood product they import and a written verification plan. The importer's
product specification must declare the maximum and minimum limits for each
relevant safety concern and the importer must have a written verification plan
that describes their affirmative steps in ensuring that a foreign firm's HACCP
program is adequate to address the hazards that are likely to affect the product
and that the HACCP plan and sanitation procedures are being consistently implemented.

The FDA final rule described five ways in which an importer can accomplish
this plan and allows importers to develop their own procedures as long as they
provide an equivalent level of assurance of compliance with the HACCP regulations.

FDA will continue to examine product at the port of entry and will also conduct
inspections at the importer's place of business. Failure of an importer to
properly verify that the seafood products have been processed under conditions
that comply with the HACCP regulations may cause the importer to be placed
on import alert.

Investigators will be asking to review the importer's product specification
to verify that the likely safety hazards for a specific product and process
are listed. Also, investigators will be reviewing the importer's records that
document the performance and results of the importer's affirmative steps.

This inspection of the importer will be handled as a domestic inspection with
all the appropriate regulatory actions available, such as seizure, injunction
and warning letters.

Answers to common questions

If FDA determines a plant's HACCP plan is unacceptable, its choice of regulatory
action will reflect the seriousness of the potential health hazard.

FDA will not preapprove HACCP plans, believing that each plan is individual
to the operation and best evaluated on site and in practice. Plan writers
are encouraged to use the Hazards and Controls Guide. A new version of the
Hazards and Controls Guide will be published in 1998.

The first inspection of a HACCP plan will be regulatory because the agency
delayed the effective date for a year making it two years following the publication
of the final rule.

However, if processors choose to make their HACCP plans available to
FDA investigators during a routine inspection between now and December
18, the investigator will review it and comment on it.

FDA sees this as helping the processor and also helping the investigators
to gain practical experience working with HACCP plans. The investigator
will leave a nonregulatory "report card" prior to December 18. (FDA will
continue to issue "HACCP report cards" after December 18 and in the aggregate
they will indicate where, as an industry, improvements need to be made
to be in compliance.)

Investigators will be checking both (1) the implementation of the HACCP
plan and (2) its adequacy. The investigator's observations are subject
to agency review by HACCP experts before regulatory action is taken.

Because of the inaccuracy of illness reporting, FDA plans to use the level
of preventive controls in place for food safety hazards between December
1997 and September 30, 1998, as the established level of compliance. Future
year rates of compliance will then be compared with this benchmark.

Overview

FDA believes the HACCP approach provides a new way to work with seafood processors.
Whereas in the past, there was an incentive to conceal mistakes for fear of
regulatory action, now it is important to document corrective action taken
to correct mistakes and to document that action. The regulatory focus, therefore,
shifts from occasions when problems occur to occasions when a processor fails
to take corrective action when a problem occurs.

FDA believes that the low acid canned food program is a model of how well
this new relationship can work.